Posts Tagged ‘Suboxone tablets pulled from market’

This week, officials of Reckitt-Benckiser, the pharmaceutical company that manufactures Suboxone and Subutex, announced its plan to stop manufacturing Suboxone tablets. The drug company says the tablets will be phased out over the next six months. According to their press releases, the company decided to discontinue manufacture of Suboxone tablets, “Because of strong evidence that the tablet form of Suboxone is linked to significantly higher rates of pediatric exposure as compared with…the film.”

Reckitt Benckiser says they are basing their action on data from the Poison Control center from September that showed there were around 8 times as many accidental Suboxone exposures in children with tablets versus films. They say they are taking action in the interest of public health.

The drug company says that since the films and tablets are clinically interchangeable, patients presently taking tablets won’t be adversely affected.

In the most recent issue of Alcohol and Drug Abuse Weekly, a spokesman for the company said per 10,000 Suboxone patients, there were .71 pediatric exposures to the film and 6.25 pediatric exposures to the tablets. These numbers were statistically significant. (1)

I believe their data. It makes sense that children would have a harder time opening one of those foil packets of Suboxone film than opening a prescription bottle of tablets. Plus, with a bottle there’s more than one dose available for ingestion, while one packet yields only one potential dose. The tablets also have an orange-y smell and taste, and may be more appealing to young children than other types of pills.

I also think Reckitt Benckiser’s film is a better product than their tablet. Most of my patients do prefer the film, saying it dissolves faster and tastes better.

However…maybe I’m too cynical when it comes to drug companies, but I don’t believe pediatric exposure is the only reason the drug company is ceasing manufacture of the tablets. I think it’s also a financial decision. The film’s patent doesn’t expire for more than ten more years, while the tablet’s patent has already expired. The Reckitt Benckiser rep for my area told me months ago that the company was considering taking the tablets off the market.

I think the recent data about pediatric overdose with tablets gave RB a great excuse to pull their tablets off the market, “For the kids…” The drug company would be open to criticism if they pulled the tablets for a purely financial motive, but who could criticize a drug company for trying to prevent the death of children? I do wonder how pediatric overdose rates of Suboxone tablets compares with other prescription opioids, but after scouring the internet can’t find that information.

I wondered how RB’s decision will affect my patients. I’m worried about a small number of my patients who, for whatever reason, didn’t like the films. These patients are all doing great in their recovery, and show no sign of medication diversion. They aren’t “bad” patients trying to scheme a way to misuse medications. Many of them have been in stable recovery, assisted by Suboxone tablets, for more than three years. All tried the film when it was released, and found it lacking. Some patients didn’t like how the films were crumbling, a problem that seems to have resolved over the last six months. I have about twenty-five people in my practice who prefer Suboxone tablets to films.

Today in my office practice I saw three patients of these patients. All of them, by the way, keep their medication locked up and safely away from children. I explained the situation to them, and told them I would like to switch them to the film, because the tablets were going to be phased out over the next six months. Two grudgingly said they would switch but wanted to wait until it was absolutely necessary. The third said he’s prefer to switch to the generic buprenorphine tablets, because he hated the film and didn’t feel like it worked nearly as well.

Overall I don’t like to prescribe generic buprenorphine in the office, because it has higher street value and is easier to misuse. Since the generic buprenorphine has no naloxone in it, it can be injected. I don’t usually prescribe it unless the patient has no insurance, is stable in their recovery with no recent IV drug use, and can’t afford name brand Suboxone. In my area, the generic buprenorphine tablets are less than half the cost of either Suboxone film or tablet. For some patients, being able to buy the cheaper generic has made it possible for them to afford to remain in treatment. Their other option would be to go to the methadone clinic, and many patients prefer treatment in an office setting, obviously.

My patient today has been in recovery for three years. He has a sponsor, goes to 12-step meetings several times per week, has never had a positive drug screen the whole three years, has a stable home, wife, kids, and also finds time to help his aging parents. I’m going to prescribe generic buprenorphine tablets for him.

This won’t be the right answer for all my patients. Some will have to try the Suboxone films again, and I hope that will work for them.

Because of this pediatric overdose information I’m going to ask every patient – on films or tablets – how they store their medication, to make sure it’s safe.